Process dominates all too often in situations where it should not, particularly in the approval of oncology drugs.

Stay Connected

You make the assertion that the Food and Drug Administration should focus more on results than on process. I think you understand that, in fact, process trumps results. Without control of process, how do we know what is not so? While I'm not wholly convinced by the FDA's actions over the last few years, moving to "results-based" drug approval will not help.

Again, a fantastic piece; I hope that you continue to share your knowledge.

-Minyan Brad

Minyan Brad -

Thanks for the kind words.

You're right that the FDA cannot operate without some process. You can't know if a trial succeeds in demonstrating a benefit outweighing the side effects without applying some biostatistical process.

My point is that process dominates all too often in situations where it should not, particularly in the approval of oncology drugs. If we're talking about a drug that smooths wrinkles, by all means process it within an inch of its life because the benefit can be erased by even small risk.

The specific situation here is a prostate cancer drug whose only crime is a biostatistical picture that is not picture perfect. Nothing so sketchy as retrospective subgroups or anything. It's just a situation where the first Phase III trials of this class of medicine taught us a few things about how they work.

Prospectively defined (though secondary and therefore not assigned alpha) statistical analyses clearly and with excellent internal consistency demonstrate a durable 4.5-month survival advantage with no serious side effects after just three treatment courses. Side effects are fever and chills -- essentially a two-day flu with each of the three injections.

The only available drug with a survival benefit in this indication, Taxotere, has debilitating, durable side effects in exchange for less than two months of extra survival after four months of weekly treatment.

If you apply the same process as used in approving wrinkle creams, this drug will not be approved. That's not appropriate for an oncology drug and would represent putting process ahead of patients. That's why I say that to turn this drug down, it would be placing process ahead of patients.

The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.